ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001619437

Ethics application status

Approved

Date submitted

1/11/2016

Date registered

23/11/2016

Date last updated

21/01/2020

Date data sharing statement initially provided

8/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

d-mannose for prophylaxis against Urinary tract Infection in Spinal Cord Injury

Scientific title

d-mannose for prophylaxis against Urinary tract Infection in SCI: Pilot Randomised control study

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1185-0605

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Spinal cord injury

Neurogenic Bladder Dysfunction

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Neurological

Other neurological disorders

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Mode of administration of d mannose: Oral tablet, 1gm three times a day for 3 months.
Strategies to monitor adherence: Weekly check of medication chart and patient interview.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control: Standard care for neurogenic bladder practised in the spinal unit. This includes, catheter care, early commencement of Intermittent catheterization program in appropriate case, hygiene, good fluid intake with the aim of 1.5 to 2 litres and education.

Control group

Active

Outcomes

Primary outcome [1]

Rate ratio of UTI: Number of UTI/Total catheter days.
Number of UTI: This will be assessed by clinical symptoms like temperature more than 38, pain, urinary leakage with positive urine culture.
Catheter days: Total number of days patients needing to use catheter to manage their bladder.

Timepoint [1]

3 months post commencement of study treatment.

Secondary outcome [1]

Frequency ratio of CUTI: Number of episodes of CUTI between treatment and control group

Number of episode of UTI: Number of symptomatic Urinary tract infection (UTI), this will be assessed by clinical symptoms like fever (temperature more than 38), pain and urinary leakage with positive urine culture.

Timepoint [1]

3 months post commencement of study treatment.

Secondary outcome [2]

Acute transfer to tertiary Hospital for UTI between two groups.
Medical records and Hospital admission records will be reviewed.

Timepoint [2]

3 months post commencement of study treatment.

Secondary outcome [3]

Time to first UTI between both groups.
Medcial records review.

Timepoint [3]

3 months post commencement of the study.

Secondary outcome [4]

Temperature associated CUTI (UTI symptoms and associated temperature elevation) between groups
Temperature associated UTI: defined as temperature more than 38 which is measured using ear thermometer with positive urine culture.

Timepoint [4]

3 months

Eligibility

Key inclusion criteria

Study population: patients admitted to Auckland Spinal Rehab Unit (ASRU).
Inclusion criteria: all new admission to spinal unit, neurogenic bladder needing catheter on admission.

Minimum age

14 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria: Repeat admission, no evidence of neurogenic bladder on admission.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

All the statistical analysis will be performed by using one or all of the statistical analytical software: R, SPSS and SAS.
Primary analysis: descriptive summary will be provided for each arm including patients ‘characteristics, number of UTI, time to first UTI within 3 months, need for acute transfer to ED, rate of CAUTI and rate of blood stream associated CAUTI.
Secondary analysis will provide descriptive summary for the safety outcomes by two groups.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/12/2016

Actual

1/03/2017

Date of last participant enrolment

Anticipated

21/12/2018

Actual

12/11/2018

Date of last data collection

Anticipated

28/02/2019

Actual

8/02/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Middlemore Hospital

Address [1]

100 hopsital road
Otahuhu
Auckland 1640

Country [1]

New Zealand

Funding source category [2]

Hospital

Name [2]

Auckland Spinal rehab unit

Address [2]

30 bairds Road
Otara
Auckland 1640

Country [2]

New Zealand

Primary sponsor type

Individual

Name

Dr Suresh Subramanian

Address

Auckland Spinal Rehab unit
30 bairds Road
Otara
Auckland 1640

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

20/10/2016

Ethics approval number [1]

16/STH/125/AM01

Summary

Brief summary

Scientific studies have shown that urinary tract infection (UTI) occurs in 40 to 50% of people who sustain a spinal cord injury. Our local audit confirms a similar percentage at the Auckland Spinal Rehabilitation Unit (ASRU) with almost half of all our patients experiencing at least one episode of UTI following spinal cord injury. Our regular practice to reduce the risk of urinary tract infection is to increase fluid intake, provide appropriate care of the catheter system, ensure good hygiene with catheter use and, when possible, discontinue the indwelling catheter or discontinue and commence an intermittent catheterization program as soon as possible.  Infections are treated with increasing water consumption and appropriate antibiotics after checking a urine culture. 

We would like to know if d mannose reduces risk of UTI in people with spinal cord injury/impairment (SCI). D mannose, which is registered as a health supplement product in NZ, has been shown to reduce the risk of urinary tract infection (UTI) in women. D mannose is a natural sugar, which binds with bacteria and prevents adhesion of the bacteria to the bladder wall thus, presumably, reducing infection in the bladder. No studies have been done to determine D mannose’s effectiveness in prevention of UTI in the spinal cord injury population. To test the effectiveness of d mannose in reducing UTI in SCI, we have developed a pilot randomised control trial (RCT) at ASRU and Middlemore Hospital (MMH).

Trial website

Trial related presentations / publications

Public notes

What is the purpose of this study: 

Scientific studies have shown that urinary tract infection (UTI) occurs in 40 to 50% of people who sustain a spinal cord injury. Our local audit confirms a similar percentage at the Auckland Spinal Rehabilitation Unit (ASRU) with almost half of all our patients experiencing at least one episode of UTI following spinal cord injury. Our regular practice to reduce the risk of urinary tract infection is to increase fluid intake, provide appropriate care of the catheter system, ensure good hygiene with catheter use and, when possible, discontinue the indwelling catheter or discontinue and commence an intermittent catheterization program as soon as possible.  Infections are treated with increasing water consumption and appropriate antibiotics after checking a urine culture. 

We would like to know if d mannose reduces risk of UTI in people with spinal cord injury/impairment (SCI). D mannose, which is registered as a health supplement product in NZ, has been shown to reduce the risk of urinary tract infection (UTI) in women. D mannose is a natural sugar, which binds with bacteria and prevents adhesion of the bacteria to the bladder wall thus, presumably, reducing infection in the bladder. No studies have been done to determine D mannose’s effectiveness in prevention of UTI in the spinal cord injury population. To test the effectiveness of d mannose in reducing UTI in SCI, we have developed a pilot randomised control trial (RCT) at ASRU and Middlemore Hospital (MMH).  

What will my participation in the study involve?: 

A randomised control trial is a study in which up to half of the participants do not receive treatment and the other half receive the trial drug, in this case, D mannose.  Randomisation of the participants means either you will be in the control group (no drug group) or in the intervention group (D mannose group).  If you are in the control group there will be no change in your management throughout your stay in Middlemore Hospital and at ASRU. If you are in the intervention group, you will receive 3 tablets of d mannose (UroFem) per day for the next 3 months. This medication will be charted in your medication chart and provided by the nursing staff just like other medications. If you miss taking a d mannose tablet, just continue with next scheduled dose.  There is no need to take any extra doses the next day.  A chart will be kept to record each tablet taken.  We will monitor you closely for any negative/adverse effects.  Previous studies have not identified any negative effects attributed to d mannose.  Although unlikely to occur, we will watch for any change in blood sugar levels in diabetic patients.  Monitoring for adverse/negative effects will be done on a weekly basis.  Should you have any questions or concerns, you are encouraged to contact your nurse or the person monitoring the medication at any time.  If you are discharged before the 3 month period ends, you will be provided with the remaining tablets for the 3 month period and a form for charting your tablets taken.  You will be contacted by phone once a week until the end of the trial period to ensure you have had no negative effects and to track your dosing of the medication. Your GP will be informed of your participation in the study.

Participating in the trial is voluntary.  Should you chose not to participate there will be no effect on your medical or rehabilitation care during your stay at MMH and/or ASRU if.  You may withdraw from the study at any time.  Your privacy will be maintained at all times.  Your name and any identifying details will be removed (de-identified) to protect your privacy.  

What are the possible benefits and risks of this study?

Potential benefit of this study: At the completion of the study we hope to identify that d mannose is an effective preventative treatment for UTI in people with SCI.  If you would like a copy of the completed study with results, we will be happy to send you a copy.  
Potential risk of this study: Considering d mannose is a dietary supplement and previous studies have not reported any significant adverse events, we expect minimal risk. However, considering d mannose is natural sugar, there may be a potential risk of changes in diabetic control and, even less likely, weight gain.  Both possibilities will be monitored weekly during the course of this 3 month study. 


Who pays for the study?

There is no cost to the participants.  If discharged before the end of the 3 month trial, you will be provided with medication to complete the trial period. 

What if something goes wrong?
In the unlikely event that you are injured due to this study, you will be eligible to apply for compensation from ACC, just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery. If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover. 

What are my rights?
Whether or not you participate is your choice.  If you do not wish to take part in the study, you do not need to give a reason. If you chose not to participate it will not affect the medical or rehabilitation care you receive.  

What happens if I change my mind?
If you decide to take part now, but change your mind later, you can withdraw from the study at any time.

Attachments [1]

/AnzctrAttachments/371754-HDEC Letter 15NTB125 Approved EXP Application.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/371754-HDEC Letter 16ST125AM01_Acknowledgement of reply to approval letter.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Suresh Subramanian

Address

Auckland Spinal rehab unit
30 Bairds Road
Otara
1640
Auckland

Country

New Zealand

Phone

+64 9 2709000

Fax

+64 9 2709001

Sureshbabu.Subramanian@middlemore.co.nz

Contact person for public queries

Name

Suresh Subramanian

Address

Auckland Spinal rehab unit
30 Bairds Road
Otara
1640
Auckland

Country

New Zealand

Phone

+64 9 2709000

Fax

+64 9 2709001

Sureshbabu.Subramanian@middlemore.co.nz

Contact person for scientific queries

Name

Suresh Subramanian

Address

Auckland Spinal rehab unit
30 Bairds Road
Otara
1640
Auckland

Country

New Zealand

Phone

+64 9 2709000

Fax

+64 9 2709001

Sureshbabu.Subramanian@middlemore.co.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Raw data sharing not included in initial ethics application, it will be saved but unable to share .

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
550	Informed consent form					371754-(Uploaded-29-11-2018-13-53-20)-Study-related document.docx
571	Ethical approval					371754-(Uploaded-14-12-2018-05-44-51)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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